Developing Nepal's medicines pricing policy: evidence synthesis and stakeholders' consultation.

Objectives: The objectives of this paper are to (a) explore stakeholders' opinions regarding Nepal's existing medicines pricing practices/situation and (b) build and present a set of medicines pricing policies for Nepal. Methods: A review of the literature and field visits to community retail pharmacies, hospital pharmacies, wholesalers, and distributor outlets in Kathmandu were conducted to assess the medicines pricing situation. Following the literature review, preliminary meetings with stakeholders and field visits were held and a draft interview guide was prepared. Consultative sessions subsequently were undertaken in Kathmandu, Nepal, in January 2023 with representatives from the Department of Drug Administration, Ministry of Health and Population, Association of Pharmaceutical Producers of Nepal, consumer groups, Transparency International, Medicines Importers Association of Nepal/ Pharmaceutical Distributors Association of Nepal, Nepal Chemist and Druggist Association, and Nepal Pharmaceutical Association. Notes were taken during these meetings regarding issues and concerns raised as well as experiences and recommendations for the future, as outlined in the interview guide. Results: The stakeholders in general stated that they do not have any objection to price regulation; however, they believe such regulation should be subject to periodic review. Both the importers and the Ministry of Health and Population have the view that an independent body/authority should be charged with regulating the prices of medicines. A set of policy options to be considered for use in Nepal include cost-plus pricing, external price referencing, internal reference pricing, and mark-up regulations. Conclusion: Key issues related to pricing were identified and suggest that a set of pricing policies and updated regulations need to be considered to establish changes that are transparent, rational, and acceptable to the related stakeholders. Hence, suggestions made in this paper could be useful to inform a rational and fair pricing structure and to improve access to medicines.

Article 4: Impact assessment of supervision performance assessment and recognition strategy (SPARS) to improve supply chain management in health facilities in Uganda: a national pre and post study.

BACKGROUND: To strengthen medicines management capacity, including supply chain management, at public sector health facilities in Uganda, the Ministry of Health introduced a multipronged supervision, performance assessment, and recognition strategy (SPARS). The aim of this study was to assess the impact of SPARS on improving supply chain management. A series of four papers on SPARS described the SPARS concept, its impact on overall and domain practices and appropriate medicines use, and now in the fourth paper describing the effect on supply chain management. METHODS: District-based health workers trained as supervisors build facility-level capacity in medicines management using an indicator-based performance assessment followed by targeted supervisory visits. From 2010 to 2013, 1222 SPARS visits were implemented, and the SPARS performance indicator scores determined. This article assesses impact on 13 indicators in three of the five SPARS domains-stock management, storage management, and ordering and reporting quality-using a pre-post design. We also explored factors that may have influenced these outcomes. RESULTS: Between the first and last visit within one year of SPARS implementation, we found an average improvement of 16 percentage points (p < 0.001) in supply chain management measures across all levels of care. The improvement in scores for stock management, storage management, and ordering and reporting was 22 (ns), 16 (p < 0.001), and 11 (p = 0.032) percentage points, respectively. The study identified the key predictors of positive change as a low initial indicator score, frequent supervisory visits, and engagement of the district health officer. CONCLUSIONS: The multipronged SPARS approach was effective in building supply chain management capacity in lower-level health care facilities with statistically significant improvements in supply chain management overall and in almost all stock and storage- management and ordering and reporting measures after one year of implementation. We recommend broad dissemination of the SPARS approach as an effective strategy to strengthen supply chain management in low-income countries. TRIAL REGISTRATION: The study did not involve or use human participants or identifiable personal data, human tissue, or animals and thus did not require ethical approval or a waiver. It is a study implemented in collaboration with the Ministry of Health and does not require trial registration.

Article 3: 1-year impact of supervision, performance assessment, and recognition strategy (SPARS) on prescribing and dispensing quality in Ugandan health facilities.

BACKGROUND: To strengthen appropriate medicine use (AMU) including the prescribing and dispensing quality at public sector health facilities in Uganda, the Ministry of Health introduced a multipronged approach known as the Supervision, Performance Assessment, and Recognition Strategy (SPARS). This paper assesses the impact of the first year of SPARS implementation on key AMU indicators. METHODS: District-based health workers trained as supervisors provide in-service training in medicines management complemented by indicator-based performance assessment and targeted supervision during each SPARS facility visit. From 2010 to 2013, health facilities that started the SPARS intervention were assessed during the first and last visit during a period of 12 months of implementing SPARS. This study examines 12 AMU indicators with 57 individual outcomes covering prescribing and dispensing quality. We also explored factors influencing 1-year improvement. RESULTS: We found an overall increase in AMU indicators of 17 percentage points (p < 0.000) between the first and last visit during a period of 12 months of supervisions, which was significant in all levels of health care facilities and in both government and private not-for-profit faith-based sectors. Appropriate dispensing (25 percentage points, p < 0.005) improved more than appropriate prescribing (12 percentage points, p = 0.13). Specific facilities that reached an average score of over 75% across all AMU measures within the first year of supervision improved from 3 to 41% from the first visit (baseline). The greatest overall impact on AMU occurred in lower-level facilities; the level of improvement varied widely across indicators, with the greatest improvements seen for the lowest baseline measures. Supervision frequency had a significant impact on level of improvement in the first year, and private not-for-profit faith-based health facilities had notably higher increases in several dispensing and prescribing indicator scores than public sector facilities. CONCLUSIONS: The multipronged SPARS approach was effective in building appropriate medicine use capacity, with statistically significant improvements in AMU overall and almost all prescribing and dispensing quality measures after 12 months of supervision. We recommend broad dissemination of the SPARS approach as an effective strategy to strengthen appropriate medicine use in low-income countries.

Inter-rater reliability and validity of good pharmacy practices measures in inspection of public sector health facility pharmacies in Uganda.

BACKGROUND: The National Drug Authority (NDA) inspects and certifies private and public sector pharmacies in Uganda using an indicator-based inspection tool that measures adherence to good pharmacy practices (GPP). 67 measures identify the situation in the domains of premises, dispensing quality, stores management, and operating requirements. Although the GPP measures are well-recognized and used internationally, little is known about their validity and reliability. The study aimed to assess validity, which measures agreement of GPP measures between a gold standard inspector and NDA inspector and inter-rater reliability (IRR), which measures agreement among NDA inspectors, of GPP measures. METHODS: We assessed validity and IRR by four teams of inspectors in eight government health facilities that represent three levels of care. Each team inspected two facilities, resulting in 24 total inspections. Each team comprised one central-level inspector, one district-level inspector, and one gold-standard inspector (i.e., a very experienced central-level inspector). We calculated median validity and IRR for each GPP measure, overall, indicator categorized as either critical, major, or minor, by domains, by the inspection decision (i.e., certified or not certified) and by adequatevalidity and IRR score (i.e., score ≥ 75%). RESULTS: The median validity for all GPP measures was 69%, with 29 (43%) measures having an adequate validity of ≥75%. The median IRR for all GPP measures was 71%, with 31 (46%) having an adequate IRR measure of ≥75%. Validity did not differ significantly by indicator category, domain or level of care. Adequate IRR and validity score (≥75%) was lowest for critical measures, which are key determinants of the certification decision, scoring 20 and 40% respectively. District inspectors had lower median validity for critical indicators and premises and higher validity for store management. Compared to central inspectors, the validity of district inspectors'certification decisions was lower; in the eight facilities, three district inspectors agreed with gold standard inspector vs. all eight central inspectors. CONCLUSIONS: Our findings question the validity and reliability of many GPP inspection measures, particularly critical measures that greatly impact certification decision. This study demonstrates the need for assessments of, and interventions to improve, validity and reproducibility of GPP measures and inspections.

Pharmaceutical system strengthening in Uganda: implementing a holistic, evidence-informed, long-term strategy.

A strong pharmaceutical sector is a precondition for effective and efficient health care and financing systems, and thus for achieving the best possible health of a population. Supported by visionary, long-term donor funds, in conjunction with mutual trust, the USAID-funded Securing Ugandans Rights to Essential Medicines (SURE) and Uganda Health Supply Chain (UHSC) program engaged in a close, more than 10 year-long (in 2018) collaboration with the Ministry of Health of Uganda. Over time, the partnership implemented numerous multi-pronged comprehensive changes in the pharmaceutical sector and conducted research to document successes and failures. We describe the evolution and key characteristics of the SURE/UHSC interventions.

Article 2: Longitudinal study assessing the one-year effects of supervision performance assessment and recognition strategy (SPARS) to improve medicines management in Uganda health facilities.

BACKGROUND: In late 2010, Uganda introduced a supervision, performance assessment, and recognition strategy (SPARS) to improve staff capacity in medicines management in government and private not-for-profit health facilities. This paper assesses the impact of SPARS in health facilities during their first year of supervision. METHODS: SPARS uses health workers trained as Medicines Management Supervisors (MMS) to supervise health facilities and address issues identified through indicatorbased performance assessment in five domains: stock management, storage management, ordering and reporting, prescribing quality, and dispensing quality. We used routine data generated during SPARS visits to 1222 health facilities to evaluate performance changes during the first year of supervision as well as the time until achieving an adequate score in this period. We also explored variables related to facilities, MMS, and intensity of implementation as predictors of performance improvement and time until achieving an adequate score. RESULTS: Health facilities received an average of 3.4 MMS visits during the first year of supervision, with an average of 88 days between visits; each MMS implemented a median of 28 visits per year. Overall SPARS scores (maximum of 25) improved by 2.3 points (22.3%) per visit from a mean baseline score of 10.3. The adjusted improvement in overall SPARS score was significantly higher in primary health care facilities (2.36) versus higher-level health facilities and hospitals (2.15) (p = 0.001). The incremental improvement was highest at visit 2, with decreasing but continuing positive gains in subsequent visits. The adjusted mean incremental improvement per visit was highest in the prescribing quality domain, followed by dispensing quality, ordering and reporting, stock management, and storage management. Adjusted improvement in SPARS scores varied by region, year of implementation, and facility ownership. After one year of SPARS, 22% of facilities achieved an adequate score of 18.75 (75% of maximum score). CONCLUSIONS: SPARS was effective in building health facility capacity in medicines management, with a median overall improvement of almost 70% during the first year. The greatest improvements occurred in prescribing quality and at lower levels of care, although the highest level of performance was achieved in storage management. We recommend broad dissemination of the SPARS approach in all Ugandan health facilities as well as in other countries seeking a practical strategy to improve medicines management performance.

Evaluating inter-rater reliability of indicators to assess performance of medicines management in health facilities in Uganda.

BACKGROUND: To build capacity in medicines management, the Uganda Ministry of Health introduced a nationwide supervision, performance assessment and recognition strategy (SPARS) in 2012. Medicines management supervisors (MMS) assess performance using 25 indicators to identify problems, focus supervision, and monitor improvement in medicines stock and storage management, ordering and reporting, and prescribing and dispensing. Although the indicators are well-recognized and used internationally, little was known about the reliability of these indicators. An initial assessment of inter-rater reliability (IRR), which measures agreement among raters (i.e., MMS), showed poor IRR; subsequently, we implemented efforts to improve IRR. The aim of this study was to assess IRR for SPARS indicators at two subsequent time points to determine whether IRR increased following efforts to improve reproducibility. METHODS: IRR was assessed in 2011 and again after efforts to improve IRR in 2012 and 2013. Efforts included targeted training, providing detailed guidelines and job aids, and refining indicator definitions and response categories. In the assessments, teams of three MMS measured 24 SPARS indicators in 26 facilities. We calculated IRR as a team agreement score (i.e., percent of the MMS teams in which all three MMS had the same score). Two sample tests for proportions were used to compare IRR scores for each indicator, domain, and overall for the initial assessment and the following two assessments. We also compared the IRR scores for indicators classified as simple (binary) versus complex (multi-component). Logistic regression was used to identify supervisor group characteristics associated with domain-specific and overall IRR scores. RESULTS: Initially only five (21%) indicators had acceptable reproducibility, defined as an IRR score ≥ 75%. At the initial assessment, prescribing quality indicators had the lowest and stock management indicators had the highest IRR. By the third IRR assessment, 12 (50%) indicators had acceptable reproducibility, and the overall IRR score improved from 57% to 72%. The IRR of simple indicators was consistently higher than that of complex indicators in the three assessment periods. We found no correlation between IRR scores and MMS experience or professional background. CONCLUSIONS: Assessments of indicator reproducibility are needed to improve IRR. Using simple indicators is recommended.

Competency in supportive supervision: a study of public sector medicines management supervisors in Uganda.

BACKGROUND: Supportive supervision has been found to be more effective than corrective fault-oriented inspections. Uganda's Ministry of Health in 2012 implemented a comprehensive strategy (SPARS) to build medicines management capacity in public sector health facilities. The approach includes supportive supervision. This structured observational study assesses supportive supervision competency among medicines management supervisors (MMS). METHOD: The study used structured observations of two groups of five purposely selected MMS-one group supervising facilities with greater medicines management improvement during one year of SPARS and one group with less improvement, based on quantitative metrics. We observed and scored behaviors and skills of supervisors in 11 categories deemed critical for effective and supportive supervision. RESULTS: Supportive supervision was not evenly or adequately implemented, with the median supportive supervision competency score for all observed supervisors being 38%. Supervisors' main strengths were problem identification, data interpretation, education, and providing constructive feedback (45%-47%). Their weakest areas were assuring continuity and setting targets (17%), and most MMS were fair to strong in effective communication, use of tools, and problem solving. MMS of facilities with little improvement in medicines management over time were weak in setting targets and promoting participation. There was a 33 percentage point difference in the median supportive supervision competency scores between MMS of facilities with more versus less improvement (57%-24%) and a 77 percentage point difference in competency between the highest and lowest scoring MMS (77%-0%). We did not find a relationship between MMS experience (number of visits implemented) and their supportive supervision competency or facility improvement in medicines management. However, there is a likely relationship between supportive supervision competency and facility improvement. CONCLUSION: Competency of MMS in supportive supervision among the sampled MMS was generally weak, but with much individual variation. Our results suggest that MMS' supportive supervision competency is positively related to the SPARS effectiveness scores of the facilities they supervise. We recommend strategies to strengthen supportive supervision behaviors and skills.

An exploratory study on equity in funding allocation for essential medicines and health supplies in Uganda's public sector.

BACKGROUND: To ascertain equity in financing for essential medicines and health supplies (EMHS) in Uganda, this paper explores the relationships among government funding allocations for EMHS, patient load, and medicines availability across facilities at different levels of care. METHODS: We collected data on EMHS allocations and availability of selected vital medicines from 43 purposively sampled hospitals and the highest level health centers (HC IV), 44 randomly selected lower-level health facilities (HC II, III), and from over 400 facility health information system records and National Medical Stores records. The data were analyzed to determine allocations per patient within and across levels of care and the effects of allocations on product availability. RESULTS: EMHS funding allocations per patient varied widely within facilities at the same level, and allocations per patient between levels overlapped considerably. For example, HC IV allocations per patient ranged from US$0.25 to US$2.14 (1:9 ratio of lowest to highest allocation), and over 75 % of HC IV facilities had the same or lower average allocation per patient than HC III facilities. Overall, 43 % of all the facilities had optimal stock levels, 27 % were understocked, and 30 % were overstocked. Using simulations, we reduced the ratio between the highest and lowest allocations per patient within a level of care to less than two and eliminated the overlap in allocation per patient between levels. CONCLUSIONS: Inequity in EMHS allocation is demonstrated by the wide range of funding allocations per patient and the corresponding disparities in medicines availability. We show that using patient load to calculate EMHS allocations has the potential to improve equity significantly. However, more research in this area is urgently needed. TRIAL REGISTRATION: The article does not report any results of human participants. It is implemented in collaboration with the Uganda's Ministry of Health, Pharmacy Division.

Article 1: Supervision, Performance Assessment, and Recognition Strategy (SPARS) - a multipronged intervention strategy for strengthening medicines management in Uganda: method presentation and facility performance at baseline.

BACKGROUND: Uganda introduced a multipronged intervention, the supervision, performance assessment, and recognition strategy (SPARS), to improve medicines management (MM) in public and not-for-profit health facilities. This paper, the first in a series, describes the SPARS intervention and reports on the MM situation in Uganda before SPARS (baseline). METHODS: To build MM capacity at health facilities, health workers were trained as MM supervisors to visit health facilities, assess MM performance, and use the findings to provide support and standardize MM practices. Performance is assessed based on 25 MM indicators covering five domains: dispensing quality (7 indicators), prescribing quality (5), stock management (4), storage management (5) and ordering and reporting (4). From the end of 2010 to 2013, MM supervisors assessed baseline MM performance of 1384 government (85 %) and private not-for-profit facilities at all levels of care in about half of Uganda's districts. RESULTS: The overall MM baseline median score was 10.3 out of a maximum of 25 with inter-quartile range (IQR) of 8.7-11.7. Facility domain scores (out of a maximum of 5) were as follows: storage management, median score of 2.9 (IQR 2.3-3.4); stock management 2.3 (IQR 2.0-2.8), ordering and reporting 2.2 (IQR 1.3-2.5), and dispensing quality 2.1 (IQR 1.7-2.7). Performance in prescribing quality was 0.9 (IQR 0.4-1.4). Significant regional differences were found: overall scores were highest in the Northern region (10.7; IQR 9.2-12.4) and lowest in the Eastern region (9.6; (IQR 7.8-11.2) (p < 0.001). Overall scores did not differ by facility ownership; however, government facilities scored lower in dispensing and storage and higher in ordering and reporting. Hospitals scored higher overall and in domains other than prescribing and stock management. Districts classified a priori as having high capacity for implementing SPARS had higher scores at baseline compared to lower-capacity districts. CONCLUSION: Assessing and building national capacity in MM is needed in both private not-for-profit and government facilities at all levels of care. The indicator-based, multipronged SPARS assessment has been described here, while the strategy's impact has yet to be documented.

First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities.

BACKGROUND: Since its inception, the Uganda National Drug Authority (NDA) has regularly inspected private sector pharmacies to monitor adherence to Good Pharmacy Practices (GPP). This study reports findings from the first public facility inspections following an intervention (SPARS: Supervision, Performance Assessment, and Recognition Strategy) to build GPP and medicines management capacity in the public sector. METHODS: The study includes 455 public facilities: 417 facilities were inspected after at least four SPARS visits by trained managerial district staff (SPARS group), 38 before any exposure to SPARS. NDA inspectors measured 10 critical, 20 major, and 37 minor GPP indicators in every facility and only accredited facilities that passed all 10 critical and failed no more than 7 major indicators. Lack of compliance for a given indicator was defined as less than 75 % facilities passing that indicator. We assessed factors associated with certification using logistic regression analysis and compared number of failed indicators between the SPARS and comparative groups using two sample t-tests with equal or unequal variance. RESULTS: 57.4 % of inspected facilities obtained GPP certification: 57.1 % in the SPARS and 60.5 % in the comparative group (Adj. OR = 0.91, 95 % CI 0.45-1.85, p = 0.802). Overall, facilities failed an average of 10 indicators. SPARS facilities performed better than comparative facilities (9 (SD 6.1) vs. 13 (SD 7.7) failed indicators respectively; p = 0.017), and SPARS supported facilities scored better on indicators covered by SPARS. For all indicators but one minor, performance in the SPARS group was equal to or significantly better than in unsupervised facilities. Within the SPARS (intervention) group, certified facilities had < 75 % compliance on 7 indicators (all minor), and uncertified facilities on 19 (4 critical, 2 major, and 13 minor) indicators. CONCLUSIONS: Half of the Ugandan population obtains medicines from the public sector. Yet, we found only 3/5 of inspected public health facilities meet GPP standards. SPARS facilities tended to perform better than unsupervised facilities, substantiating the value of supporting supervision interventions in GPP areas that need strengthening. None compliant indicators can be improved through practices and behavioral changes; some require infrastructure investments. We conclude that regular NDA inspections of public sector pharmacies in conjunction with interventions to improve GPP adherence can revolutionize patient care in Uganda.

Cotrimoxazole prescribing by dispensing and non-dispensing doctors: do they differ in rationality?

BACKGROUND: Dispensing doctors (DDs) have been found to prescribe significantly more drugs, more injections and more antibiotics per patient than non-dispensing doctors (NDDs). However, the rationality of prescription in relation to diagnoses and symptoms has not been studied. OBJECTIVES: To identify and assess differences in the rationality of cotrimoxazole prescription by DDs and NDDs evaluated by drug choice and dosage in relation to diagnoses and symptoms. METHODS: Cohort study of 28 private sector DDs and 25 NDDs in Zimbabwe, using retrospective data from 688 patient records. Drug choice and dose in relation to the recorded diagnoses and symptom(s) were assessed. A new method was developed and tested to measure rationality in a specific and realistic way. A 'correctness-score list' was developed based on a panel of four evaluators assessing the rationality of cotrimoxazole prescription in relation to diagnoses and symptoms. This list was then used as a reference for the assessment. RESULTS: The two groups of prescribers did not differ significantly with respect to rationality of drug choice. Both DDs and NDDs prescribed cotrimoxazole to patients for diagnoses and symptoms for which cotrimoxazole could not be justified (41.4%vs. 43.5%). DDs compared with NDDs used subcurative doses more often (26.4% of the encounters compared with 11.7%; P = 0.035) and correct doses less frequent (58.0% compared with 72.6%; P = 0.047). CONCLUSION: The prescription of cotrimoxazole by both DDs and NDDs was widely irrational. They prescribed cotrimoxazole too frequently, and DDs used subcurative doses to a wider extent. By this prescribing practice, both groups, but especially the DDs, contribute to increasing health hazards, cost and risk of developing bacterial resistance. The method for assessing rationality of drug prescribing was found feasible, and it is recommended that it be further tested and developed.

Prescription habits of dispensing and non-dispensing doctors in Zimbabwe.

The number of dispensing doctors has increased in the last decade, but the implication of this trend on the quality of health care and drug use is unknown. We present a comparative drug utilization study of 29 dispensing doctors and 28 non-dispensing doctors in Zimbabwe based on standard indicators developed by the World Health Organization. Dispensing doctors prescribed significantly more drugs per patient than non-dispensing doctors (2.3 versus 1.7), injected more patients (28.4% versus 9.5%), and prescribed more antibiotics (0.72 versus 0.54) and mixtures (0.43 versus 0.25) per encounter. Dispensing doctors also spent significantly less time on each encounter (8.7 min versus 13.0 min) than their non-dispensing colleagues. The use of generic name, brand name and essential drugs did not differ significantly between the two groups of practitioners. Multivariate analyses controlling for gender, race, place of education, location of practice and patients seen per day showed that dispensing by doctors was associated with less clinically and economically appropriate prescribing. These findings suggest that the quality of health care--as related to drug use, patient safety and treatment cost--is lower with dispensing doctors than with non-dispensing doctors.